Device recall
Z-1060-2019: Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG…
FDA device recall · Class III · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1060-2019 |
|---|---|
| Recall event | 82272 |
| Product | Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT Product Usage: The reusable ECG trunk cable enables ECG monitoring with GE… |
| Product code | IKD |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 19, 2020 |
| FEI number | 2126677 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database